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Technical Leader Required with Exp in designing Medical Devices

Question asked by Rahul Ahuja on Jan 19, 2017

 

Job Specific Information

Title:

Lead Design Engineer (mechanical)

Reporting to

Project Manager

Division / Function

AMEA R&D – India.

Location:

India: Gurgaon or any other city as required.

Job Code:

FLSA Status (US Only):

Exempt

Created:



Revised:

Level:

Principle Engineer / Sr. Engineer

Job Type (highlight)

Program Management

Functional Management

Technical Leader

Contact Details

Rahul Ahuja - +91 9810447547, rahul@aarchconsulting.com

Job Description



The candidate needs to be a self-motivated individual skilled inleading Design and development phase of medical device product development and product lifecycle management. Strong technical background in medical device (Class II & III). Lead a team of design & development engineers to develop and deliver product design, process development, verification and validation as per defined CTQ’s. . Requires in-depth knowledge and experience in developing 3D CAD modeling, 2D Drafting, Geometric Dimensioning & Tolerance, Tolerance Stack Up Analysis, Basic Engineering Calculations and Value Engineering. The candidate may also be required to participate in concept development and evaluation.

The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures. Should be comfortable working in a matrix organizational structure.

Key Responsibilities / Deliverables

 

  • Product Design:
    • CAD – computer aided design software - 3D and 2D CAD modeling
      • Proficiency in Modeling s/w like Unigraphics/Solidworks/Pro-E / Abacus is a must
      • Electronic document management system based design history file management
      • Working Knowledge of complex Surface modeling will be added advantage
      • Must be able to work on a complex assembly modeling
  • Engineering Analysis – FEA, CAE and hand calculations
      • GD&T, tolerance stack ups.
      • Able to construct analytical models e.g. finite element analysis, kinematic models, computational fluid dynamics, to predict real world performance.
    • Design Verification & Testing
    • Liaison with Mfg. team for implementing Design for Manufacture(DFM) and DFA.
    • Risk Analysis – FMEA, Cause & Effects analysis.
    • Working with QA engineers to identify applicable industry standards and product design bench marking
    • Knowledge of Basic engineering analysis - Free-body & stress-strain analysis
    • Working knowledge on ANSYS or any other analysis software tool will be added advantage.
  • Project & Process Management:
    • Liaison with NPD marketing team and customers for product testing & validation
    • Implementation & Execution of NPD process as per companies quality systems (e.g. ISO 13485, Risk Management ISO guidelines, .
    • Project co-ordination within team and external partners.
    • Project management skills with proficiency in MS project or similar tools.
    • Process Knowledge on DFSS knowledge & certification or New Product Development is preferred.
  • Should be creative with an aptitude for problem solving.
  • Should have ability to create concepts that meet design requirements.
  • Should have ability to conduct design of experiments and analyze desired results.
  • Should be able to work in a team environment
  • Candidates having Patents will get preference.
  • Assign roles & responsibilities to design team as per project plan



Academic Qualification and Experience

  • Masters(or higher) degree in engineering with preference mechanical engineering,plastics and polymer engineering and biomedical engineering.
  • 8+ years of R&D / NPD experiences in medical devices. (Candidates with exceptional skill sets with experience in alternative high precision industries like automotive, aeronautics may be considered).
  • Mechanical Engineering with specialization in product design, tool design etc.
  • Value Engineering, Creative Thinking, Design to Value solution development experience.
  • Knowledge in medical grade material sciences  and processing – Metals, Polymers, plastics
  • Proficient in CAD Design, GD&T, Tolerance stack-ups
  • Should have knowledge of quality system & processes that needs to be applied for product development (Preferably worked for an ISO certified organization).
  • Project Management with proficiency in MS project or similar tools.


Soft Skills

  • Excellent Communication, presentation and interpersonal skills with proficiency in English (verbal and written).
  • A positive attitude, innovative and creative thinker.
  • Responsible risk taking and risk management.
  • Experience in working with global and virtual team and working in a cross cultural environment.


Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.For those individuals that supervise others, the following statements are applicable:

  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Outcomes